We are internationally recognized as experts in advanced aseptic processing and risk-based isolation and barrier technologies. Our experience, awareness and understanding of industry trends places importance on time-to-market, plant flexibility and cost control to avoid costly project delays and minimize risk.
- 300+ Years of Combined Aseptic Processing Experience
- Worldwide Aseptic Design Capabilities; Successfully Completed Aseptic Projects on 5 Continents; Placed over $3B in Aseptic Capital Projects
- Breadth of Experience: Quality, Engineering, Aseptic Production, Packaging, Maintenance, Validation, Development and Regulatory
- Strategic Business Planning for Advanced Aseptic Processing
- Compliance Risk Evaluations and Assessments
- Outstanding Relationships with Respected Aseptic Processing Equipment Vendors
- Using Sterile Enclosure Technology for OEL Containment and Performing Aseptic Manipulations such as liquids into nested syringes
- Experienced in the application of FDA, EU Annex 1, Canada, China, Japan, Brazil and World Health Organization Regulations and Guidance
- Designed and Upgraded over 20 Filling / Capping Lines to meet EU Annex 1 guidance.
- Advanced Aseptic Team of Subject Matter Experts who Lecture Worldwide and Contribute to Prominent Industry Publications
- Knowledge of State-of-the-Art Advanced Aseptic, RABS and Isolation/Barrier Technologies